Dialysis device

ABSTRACT

A dialysis device comprising a prescriber interface and a programming means configured to allow, via the prescriber interface, input of a set of therapeutic objectives and a treatment plan and a re-evaluation means configured to, as a function of the therapeutic objectives and the treatment plan, suggest at least one treatment option comprising a set of settings of a treatment session to achieve said set of therapeutic objectives.

FIELD OF THE INVENTION

The present invention concerns the field of dialysis treatment. Itrelates more particularly to a dialysis device comprising an automatedperitoneal dialysis machine or a hemodialysis machine that, based oninput of certain data, is programmed to carry out a treatment session.

BACKGROUND OF THE INVENTION

Treatment of a patient with renal insufficiency is typically carried outaccording to a treatment plan created by a prescriber, such as aphysician, based on certain therapeutic objectives. The treatment planmay comprise a schedule of treatment sessions and specific settings foreach scheduled treatment session. The treatment plan typically alsoincludes dietary advice, medications, frequency of blood samples forfollow-up etc.

Treatment of renal insufficiency typically takes place in individualtreatment sessions. One session may have duration between 1 and 12hours.

Certain conditions may effect the actual execution of the treatment planand the resulting treatment. One condition may be related tomodifications of the treatment settings according to the wish of thepatient. Such a modification may typically be the extension orshortening of duration of the treatment session. Another condition maybe related to changes due to clinical conditions such as limitedachievable blood flow, unexpectedly high weight gain, technical failureor a hypotensive episode. A further condition may be related to theactual result of a preceding treatment session.

A number of dialysis devices are known (see, for example, U.S. Pat. No.5,326,476) in which the treatment parameters (duration, flow rate, etc.)are programmed by a prescriber such as a physician or a technician.

There are also devices (see, for example, U.S. Pat. No. 5,788,851) whichare designed to allow a patient, or even a member of the patient'sfamily assisting the patient, to interact with the programming of thetreatment. In such devices, the interaction between patient and deviceis effected via an interface, for example implemented on a touch screen.

However, the devices provided with a patient interface, such as aredescribed in the prior art, are not programmed in such a way as todefine therapeutic or clinical objectives to be achieved, for example apredefined creatinine clearance value, a given dose defined as a Kt/Vratio where K=clearance of urea (ml/min), t=time on dialysis (min),V=volume of urea distribution in the body (ml), an individualized waterremoval target, a sodium balance.

Moreover, if treatment settings are modified by the patient, the devicesof the prior art are limited to verifying the desired modification.

There is therefore a need to provide a dialysis device and a methodwhere certain data inputs e.g. in the form of treatment sessionsettings, results in at least one suggested treatment option securingthat the therapeutic objectives initially fixed by the prescriber areachieved.

SUMMARY OF THE INVENTION

It is an object of the present invention to at least partly overcome oneor more of the above identified limitations of prior art. Specificallyit is an object to provide an improved dialysis device securing that atreatment objective is reached while allowing flexibility in theindividual treatment sessions. This may be achieved by means of adialysis device comprising a prescriber interface and a programmingmeans configured to allow, via the prescriber interface, input of a setof therapeutic objectives and a treatment plan and a re-evaluation meansconfigured to, as a function of the therapeutic objectives and thetreatment plan, suggest at least one treatment option comprising a setof settings of a treatment session to achieve said set of therapeuticobjectives.

The treatment plan defined by the prescriber is generally intended for aperiod or a number, n, of consecutive treatment sessions.

The set of settings comprises a number of individual settings whereinthe individual setting may be duration of treatment session, blood flow,fluid removal rate, total removed fluid volume, dialysis fluidcomposition, dialysis fluid flow rate, dialysis fluid temperature,dialyzer type, treatment session schedule, number of exchanges persession, frequency of exchanges, fluid volume per exchange, duration ofeach dwell and glucose concentration in dialysis fluid.

An individual therapeutic or clinical parameter may be creatinineclearance, Kt/V ratio, ultrafiltration, sodium elimination, weight ofthe patient, total body water or blood pressure.

A treatment option would typically comprise a set of settings for atreatment session that together will result in reaching the therapeuticobjectives.

In one embodiment of the invention the dialysis device comprises apatient interface and a modification means configured to allow, via thepatient interface, modification of at least one of said settings whereinthe re-evaluation means is configured to, as a function of the modifiedsetting, suggest the at least one treatment option.

Various settings may be modified in accordance with the patient'swishes. The dialysis device is configured to suggest at least onetreatment option including the modified setting(s) where one or severalother settings of the session have been changed as a consequence of thesetting(s) modified according to the patient's wishes. One settingmodified by the patient may result in several suggested treatmentoptions since a modification may be compensated for in several differentways.

In one embodiment of the invention the patient may modify settingsduring an ongoing treatment session. In this case as a consequence ofthe modifications, at least one treatment option may be offered at theconsecutive session or sessions.

In one embodiment of the invention the dialysis device comprises acondition-determining means that is configured to measure clinical ortherapeutic parameters wherein the re-evaluation means is configured to,as a function of the measured parameters during an on-going treatmentsession or measured parameters of at least one preceding treatmentsession, suggest the at least one treatment option. In anotherembodiment of the invention the re-evaluation means is configured tosuggest the at least one treatment option as a function of the modifiedsetting via the patient interface and the parameters measured by meansof the condition-determining means.

According to a further embodiment of the invention the patient interfaceis configured to allow the patient to select one of the suggestedtreatment options whereby the dialysis device adjusts the settings inconsequence of the selection to carry out the treatment session inaccordance with the selected treatment option.

In one embodiment of the invention the patient interface is configuredto display an indication of the result of the treatment in relation tothe set of therapeutic objectives as measured by means of thecondition-determining means. The result of the treatment in relation tothe set of therapeutic objectives may be graphically displayed in theform of a graph, bar chart or an indicator gauge.

The main indication offered to the patient at the end of each treatmentand/or at the start of programming may be a percentage attainment of theobjectives, e.g. with a percentage figure of 85% signifying that thepatient is in deficit by 15% relative to the therapeutic objectives thusvisualizing adequacy of the treatment as a whole or each of theparameters indicative of the adequacy of the treatment.

In a further embodiment of the invention the programming means isconfigured to allow input, via the prescriber interface, limits ofvariation of each of the at least one setting that are allowed to bemodified via the patient interface thereby allowing modification of eachsetting within these limits.

In one embodiment of the invention a modification of a setting mayresult in that the patient is advised to accept a certain treatmentoption rather than one of several options.

The programming means may also be configured to allow input, via theprescriber interface, of limits of variation of the measured clinical ortherapeutic parameters. In one embodiment the dialysis machine comprisesan alert means configured to issue an alert upon a deviation above orbelow a predefined limit of variation of a measured clinical ortherapeutic parameter.

In a further embodiment of the invention the patient interface comprisesa display configured to display the at least one suggested treatmentoption. The display means being functionally linked to the re-evaluationmeans.

In a further embodiment of the invention the patient interface and/orthe prescriber interface is comprised by a graphical user interface. Inone embodiment of the invention the graphical user interface is a touchscreen.

In a further embodiment of the invention the dialysis device comprises aprescriber interface and a programming means configured to allow, viathe prescriber interface, input of a set of therapeutic objectives and atreatment plan and a condition-determining means that is configured tomeasure clinical or therapeutic parameters during an ongoing orresulting from a treatment session wherein the patient interface isconfigured to display the result of the treatment in relation to the setof therapeutic objectives as measured by means of thecondition-determining means.

In one embodiment of the invention, the patient is requested to respondto very specific clinical questions before modifying his treatment. Suchresponses may prevent the modification of said treatment. This set upmay be referred to as a decision tree. The decision tree may also takeinto account information from recorded and/or measured parameters inorder to better orient the patient and/or the treatment options as afunction of the details gathered with the aid of these questions. Theresponses given by the patient will be communicated to the prescriber inthe context of a medical monitoring of the patient after a reasonabletime or, if appropriate, immediately, depending on the possibleconsequences on the state of health or therapeutic monitoring of thepatient.

According to a first aspect of the invention the dialysis devicecomprises an automated peritoneal dialysis machine also referred to as acycler. According to a second aspect of the invention the dialysisdevice comprises a hemodialysis machine.

The dialysis device according to the invention may be usedadvantageously in the context of home peritoneal dialysis and homehemodialysis respectively. In addition the dialysis device in the formof a hemodialysis machine may be used in a clinic or a self caresetting.

DETAILED DISCLOSURE OF THE INVENTION

Below will be described the first and the second aspects of theinvention, respectively, by way of illustrative examples.

First Aspect:

According to the first aspect of the invention where the dialysis devicecomprises an automated peritoneal dialysis machine, also referred to asa cycler, the dialysis treatment is performed by introducing dialysisfluid into the peritoneal cavity of a patient. The dialysis takes placeover the peritoneum. After a period of time, typically 2 hours, the useddialysis fluid is drained from the peritoneal cavity and fresh dialysisfluid may be entered for continued treatment either directly or with atime delay. The dialysis fluid is usually available as a sterilizedbagged fluid. For a treatment session during e.g. 8 hours multiple bagsof fluid are used. The peritoneal dialysis machine in a cyclic mannerassists in filling the peritoneum with fresh dialysis fluid from one bagat the time, possibly via a heater bag for heating the dialysis fluid tobody temperature, and after a period of dwell draining the peritoneumand transferring the used dialysis fluid to a drain bag or to a drain.

By means of the dialysis device according to the present invention it ispossible to provide for an optimized use of the available fluids as afunction of the duration of the treatment session.

Example i

It is possible to reduce the duration of the dwell period in such a wayas to ensure that the fluid from all bags is utilized during theavailable time for the treatment session while adhering to the intendednumber of fluid exchanges.

According to one embodiment of the invention various treatment settingsmay be modified by the patient. In addition to the duration of atreatment session, it is also possible to modify the total volume of thedialysis fluid during a treatment session, the dialysis fluidcomposition or the number of exchange cycles, where one exchange cyclecomprises filling, dwell and drain of dialysis fluid originating fromone bag.

In peritoneal dialysis, the therapeutic objectives to be reached over aperiod of n sessions may include one or more of the following:beta-2-microglobuline clearance, creatinine clearance, urea clearance,urea reduction ratio (URR), Kt/V ratio, sodium elimination,ultrafiltration volume, ultrafiltration rate, weight of the patient,blood chemistry parameters, haemoglobin and blood pressure. The bloodchemistry parameters may include serum levels of phosphate, sodium,calcium, potassium, bicarbonate, albumin, urea or creatinine.

The at least one suggested treatment option for a period of nconsecutive treatment sessions is advantageously adapted to theparameters measured during the preceding m treatment sessions. Suchparameters may be measured by the condition-determining means e.g. inthe form of an ultrafiltration measurement means, a patient scale, bloodsamples or a means for analysis of effluent (drained dialysis fluid).The patient's glucose level may also be monitored during the treatmentsession by means of the condition-determining means. It is also possibleto measure the glucose level in the drained dialysis fluid.

According to one embodiment of the first aspect of the invention, theparameters measured during the preceding m treatment sessions includeone or more of the following measurements: change in patient's weight,change in patient's blood pressure, change in patient's fat mass,quantity and nature of patient's food intake, quantity of water absorbedby patient, effective ultra-filtration, temperature of patient, physicalstrength of patient, residual renal function, urea removal, creatinineremoval, change in blood parameters such as sodium, phosphate, calcium.

Example ii

The number n of consecutive peritoneal dialysis treatment sessions maybe performed during a period lasting between 3 and 30 days, e.g. 7 days.

Example iii

The number m of preceding peritoneal dialysis treatment sessions mayhave been performed during a period lasting between 3 and 30 days, e.g.7 days.

According to one embodiment of the invention, a compensation of atreatment result is achieved by requiring the patient, for a consecutivetreatment session, to correct the effects of the preceding sessions,limiting the freedom of modification. In this case, the patient ispreferably forced to choose from at least one of the followingconstraints: minimum duration of treatment, modification of the dialysisfluid composition or combination of dialysis fluid compositions,modification to the number of exchange cycles or to the exchange volume,modification of water intake between treatment sessions, addition offurther exchange sessions during the day, or modification of thedialysis fluid composition used during these exchanges.

In one embodiment of the invention medical personnel responsible for thetreatment of the patient is informed automatically by an alert when adeviation above or below a predefined limit is detected in relation tothe therapeutic objectives that have been defined for the patient. Theinformation may be transferred to the medical personnel remotely, forexample by telephone or by Internet link.

Example iv

In case of peritoneal dialysis a deviation of ±30% over a 24-hour periodmay be accepted, provided that the weekly objective of, for example, 7litres of ultrafiltration and 70 litres of creatinine clearance isachieved. The Kt/V objective may be 2.3.

The prescriber may take into account the filtration surface of thepatient's membrane, its transport quality (high, medium or low), theresidual renal function, and the body mass and clinical parameters suchas weight, blood pressure and total body water when designing thetreatment plan.

The prescriber in cooperation with the dialysis device configured forperforming peritoneal dialysis defines the rules forming basis for thetreatment options suggested by the re-evaluation means.

Example v

If the ultrafiltration falls below 700 ml on one day, a modification ofthe glucose or sodium concentration of the dialysis fluid and/or theaddition of other colloidal osmotic pressure solutions during thetreatment and/or the daily exchange or exchanges will be suggested as atreatment option by the re-evaluation means. Alternatively, if theestimated clearance, on account of the reduced duration of the exchangesfrom 12 hours to 8 hours one night, drops by more than 30%, increase thenumber of exchanges the following night or prolong the duration of thetreatment session from 10 hours to 13 hours, or else add supplementarydaytime exchange sessions.

The patient may vary the duration of the treatment session from one dayto another.

Example vi

As a function of the preceding sessions, the device may permitprogramming a duration of a treatment session of between 8 and 12 hoursin normal time, or of between 10 and 14 hours if it registers acumulative therapeutic deficit due to treatment sessions that are tooshort in the last few days, or of a minimum of 14 hours if this deficitis deemed to be too great, or may even propose a supplementary daytimetreatment session. The other parameter on which the patient may act isthe water/sodium intake and/or the ultrafiltration in case of weightgain. Such intake or ultrafiltration parameters may as well form part ofa suggested treatment option.

Second Aspect:

According to the second aspect of the invention where the dialysisdevice comprises a hemodialysis machine the treatment may be carried oute.g. in a clinic where the patient is assisted by e.g. by a nurse, in aself care setting or at a patient's home. As disclosed above, thetreatment of a patient with renal insufficiency is carried out accordingto a treatment plan created by a prescriber.

The therapeutic objectives for a hemodialysis treatment typicallyinclude dialysis dose per unit of time, the patients so called “dryweight” and target ranges for various blood parameters. The “dry weight”is the weight at which the patient should be at the end of thetreatment, that is, after fluid removal. Blood parameters of importancemay be blood pressure, hematocrit, serum phosphate, serum potassium,serum sodium etc. For each parameter, a target range is specified. Thedialysis dose may be specified for each treatment, e.g. as URR (UreaReduction Ratio) or spKt/V (Single Pool Kt/V) or similar, or for alonger time, e.g. weekly stdKt/V (Weekly Standard Kt/V).

The treatment schedule may be specified as one treatment session thriceweekly for a fixed period of time, typically 3-5 hours. Alternatively atreatment session may be scheduled every other day (i.e. 3.5 times perweek), daily (i.e. 5-6 times per week, typically 2 hours) or during thenight while sleeping, often referred to as nocturnal treatment (e.g. 3-6times per week). The treatment schedule may be anything between theseschedules, or a mix of two or more schedules, e.g. a mix of short dailyand nocturnal treatments.

Settings defining each treatment session comprises e.g. dialyzer type,dialysis fluid composition, dialysis fluid temperature, dialysis fluidflow rate, target blood flow and treatment duration. Typically also thetargeted weight loss is entered for each treatment session. The targetedweight loss is based on how much the patient weighs before treatment andknowledge of the prescribed dry weight.

In addition to prescribing a treatment schedule and settings for eachtreatment session, the prescriber may also set limits on allowedvariation for each resulting setting. The limits are chosen by theprescriber to be safe for the patient, yet allow flexibility in how theindividual dialysis treatment sessions are performed. For example, theprescriber may set a maximum allowed weight loss rate of 800 ml/min, toavoid hypotension which is a potentially dangerous condition.

Below are disclosed two exemplary treatment plans. In the exemplarytreatment plans the target blood parameters and the dialysis fluidcomposition have been left out for simplicity. However, the parametersdisclosed serves to illustrate the second aspect of the invention.

Treatment of patient A (daily dialysis e.g. performed in a homehemodialysis setting):

-   -   Therapeutic objectives        -   Dialysis dose: weekly stdKt/V=3.0        -   Dry weight: 85 kg    -   Treatment plan        -   Treatment schedule            -   6 times per week: Monday-Saturday        -   Treatment session settings            -   Dialyzer: Polyflux 170H            -   Fluid flow: 500 ml/min            -   Blood flow 350 ml/min            -   Duration: 2.5 hours

Treatment of patient B (thrice weekly dialysis e.g. performed asin-center hemodialysis, either self-care or assisted):

-   -   Therapeutic objectives        -   Dialysis dose: spKt/V=1.2        -   Dry weight: 72 kg    -   Treatment plan        -   Treatment schedule            -   3 times per week: Monday, Wednesday, Friday        -   Treatment session settings            -   Dialyzer: Polyflux 140H            -   Fluid flow: 500 ml/min            -   Blood flow 350 ml/min            -   Duration: 5 hours

The data representing the therapeutic objectives, the treatment plan(including schedule of treatments and session settings) and variationlimits are entered into a programming means of the hemodialysis machine,via a prescriber interface. The prescriber interface may form part ofthe hemodialysis machine itself. Alternatively, the dialysis devicecomprises several parts such that the prescriber interface is separatefrom the dialysis machine itself.

One embodiment of the second aspect of the invention is related to homehemodialysis where the patient treats himself at a home setting,possibly assisted by e.g. a family member. A home dialysis devicecomprises two separate components; a computer system at the clinic andthe hemodialysis machine in the patient's home. The computer system atthe clinic comprises the prescriber interface, where the prescriberenters the treatment plan. The treatment plan may be electronicallytransferred to the hemodialysis machine, e.g. via a portable electronicmedia such as a USB memory or via a direct electronic connection bytelephone line or internet. Once the treatment plan is transferred tothe hemodialysis machine the treatment may commence without furtherchanges.

One embodiment of the second aspect of the invention is related todialysis treatment performed in an in-center setting where the patientis assisted by a physician or a nurse. In the in-center clinic, eachhemodialysis machine will serve several patients. The dialysis devicefor the in-center setting may comprise a single computer system for thewhole clinic and several hemodialysis machines. The treatment plan foreach patient is stored on the computer system until the patient to betreated has been assigned to a specific hemodialysis machine. Thetherapeutic objectives and/or the treatment plan may be transferred tothe hemodialysis machine via an electronic network. Alternatively thetherapeutic objectives and the treatment plan may be transferred to thehemodialysis machine from a personal portable memory device, such as aUSB memory or an electronic patient card. Once the therapeuticobjectives and/or the treatment plan is transferred to the hemodialysismachine the re-evaluation means will suggest at least one treatmentoption and the treatment may commence without further changes once oneof these options is selected via the patient interface.

According to one embodiment of the second aspect of the invention thepatient interface allows for modifications of any of the resultingtreatment settings. Reasonable modifications to the settings is allowedto be made via the patient interface, i.e. modifications are allowed aslong as they are within limits set by the prescriber e.g. the durationof a treatment session may be set between 3 and 7 hours and it will notbe possible to enter a duration of treatment session outside theselimits.

Example I

Patient B according to the above exemplified treatment plan, may want toshorten the duration of the treatment session from 5 to 4 hours on aparticular day. If this new duration of treatment is within the setlimits the modification is allowed.

Based on a modified setting the re-evaluation means determines how othertreatment settings may be changed to achieve the therapeutic objectivesand suggests at least one treatment option. The re-evaluation means mayalso take into account other available data of the patient such as thetreatment history and current treatment parameters when suggesting newtreatment options to achieve the therapeutic objectives.

Example II

Patient A according to the above exemplified treatment plan, has gained3.0 kg since the last treatment session, a weight which has to be takenoff to reach the therapeutic objective of the dry weight. The maximumallowed weight loss rate may have been set to 800 g/hour, in which casethe maximum total weight loss that may be achieved in the prescribed 2.5hour treatment is 2.0 kg. The re-evaluation means suggests a treatmentoption where the duration of the treatment is prolonged to 3 hours and45 minutes, which allows the dry weight to be reached while maintaininga safe weight removal rate. The re-evaluation means may suggest a secondtreatment option, where a weight loss of only 2.0 kg in the currenttreatment session is reached, leaving a “debt” until the next treatmentsession.

Example III

During a treatment of Patient B, the maximum blood flow that may beachieved is 300 ml/min due to that the needles have been somewhatmisplaced during cannulation. This is lower than the blood flow of 350ml/min according to the entered treatment plan. Thus, the treatment dose(spKt/V=1.2) will not be reached as planned. The re-evaluation meanssuggests a treatment option showing an increase of the dialysis fluidflow rate from 500 to 800 ml/min. If increase of dialysis fluid flow isnot sufficient to reach the treatment dose objective, additionally there-evaluation means will suggest a treatment option where the treatmenttime is extended. Alternatively, the re-evaluation means may suggest atreatment option resulting in that a dose “debt” is left for the nexttreatment session or treatment sessions.

As exemplified above, there may be one or several options for thepatient to choose from to reach the therapeutic objective.

In one embodiment of the invention the patient interface displays a listincluding at least one setting that may be modified.

Example IV

If Patient B in the example above decides that an extension of treatmenttime of 15 minutes is acceptable, then he/she sets the treatment time tobe 5 hours and 15 minutes—and the re-evaluation means dynamically showshow high the dialysis fluid flow has to be to reach the treatment dosetarget. Once the user has decided that the suggested combination ofparameters are acceptable, they are accepted via the patient interfaceand the hemodialysis machine dynamically makes the necessaryadjustments.

In an alternative embodiment of the second aspect of the invention thehemodialysis machine comprises a condition-measuring means providingdata so as to determine how well the therapeutic objectives are reached.Some therapeutic objectives are possible to measure or estimate e.g. thedialysis dose, which may be measured using blood samples analyzed forBUN (Blood Urea Nitrogen), or estimated using on-line clearanceestimating technology. Thus, the re-evaluation means may take intoaccount measurements conducted by the condition-measuring means whensuggesting treatment options to achieve the therapeutic objective of thetreatment dose. Parameters such as plasma phosphate content may beevaluated by means of blood samples in order to follow up how welltherapeutic objectives on such parameters are achieved. Results of bloodsample analysis is preferably entered into a treatment history recordwhereby the re-evaluation means may be configured to use the patienthistory data for suggesting consecutive treatment options.

In an alternative embodiment of the second aspect of the invention, there-evaluation means takes into account the treatment history as well asseveral future treatment sessions when suggesting a treatment option, aswill be described below. In addition to the treatment plan, thisrequires storing treatment history of each patient. In the homehemodialysis setting the treatment history may be stored in the memorycomprised by the control system of the hemodialysis machine, since it isbeing used by a single patient. In the case of in-center dialysis, thetreatment history of each patient has to be stored either on the cliniccomputer system (e.g. via network) or on a personal portable memorydevice. The data representing the patient history would typicallyinclude data related to previous treatment sessions (time and date,duration, blood flow or blood volume processed, fluid flow, dialysisfluid composition, weight loss, achieved online clearance etc) andpossibly also indicators of therapeutic objectives (achieved dialysisdose, pre-dialysis weight, blood parameters such as pressure,haemoglobin, etc). The patient history to be taken into accounttypically comprises the treatment sessions during 7 preceding days.

Example V

If Patient A has a weight loss “debt” from an earlier treatment session,as suggested in the example above, the re-evaluation means would suggesta treatment option having longer treatment duration. If the weight lossdebt is significant, the re-evaluation means may suggest a treatmentoption where the weight is removed over several future treatmentsessions.

Example VI

If patient A has one or more treatment sessions with clearanceefficiency below what is expected by the prescriber (e.g. due to reducedblood flow or reduced time), the re-evaluation means will suggest atreatment option at start of the next treatment session to achieve thetargeted weekly dose of stdKt/V=3.0. This treatment option may compriseincreasing dialysis fluid flow, increasing blood flow, increasing timeor choosing a different dialyzer with a larger membrane surface area.

Example VII

If Patient A knows that he will have limited time for treatmenttomorrow, he may choose to increase duration of the treatment sessiontoday, for example from 2.5 hours to 3.5 hours. This will increase thedialysis dose today and thus put him/her ahead of schedule in achievingthe weekly dose target. The re-evaluation means will then suggest ashorter time for the treatment tomorrow.

Examples VI and VII indicate that the patient may be below as well asabove a therapeutic objective, in these examples the weekly dialysisdose target. The patient interface according to the invention thereforeincludes an indicator that in a simple and understandable fashion showshow well the therapeutic objectives are reached. This may be in theshape of a percentage figure, e.g. 85%, or a graphical representationsuch as a bar graph. The achievement of therapeutic objectives may alsobe shown over time, e.g. by a diagram with time on the horizontal axis.For example, if the therapeutic objective is the weekly dialysis dose,the graph may display the target as a horizontal line, and the actuallyachieved dose may be represented as connected points, where each pointrepresents the achieved weekly dose over the last 7 days.

As stated above the dialysis device may comprise a condition-determiningmeans configured to measure parameters relevant for the therapeuticobjective. The condition-determining means may comprise e.g. an onlineclearance estimating device, a blood pressure monitor, a bloodcomposition analyser, a patient scale. The condition-determining meansmay be configured to detect failure to meet the therapeutic objectivesand to issue an alert to the patient (via the patient interface) and/orto the prescriber via e.g. telephone line or internet connection.

All of the steps, as well as any sub-sequence of steps, described above(comprising the first as well as the second aspect thereof) may becontrolled by means of a programmed computer apparatus forming part ofthe dialysis device. Moreover, although the embodiments of the inventiondescribed above comprise computer apparatus and processes performed incomputer apparatus, the invention thus also extends to computerprograms, particularly computer programs on or in a carrier, adapted forputting the invention into practice. The program may be in the form ofsource code, object code, a code intermediate source and object codesuch as in partially compiled form, or in any other form suitable foruse in the implementation of the procedure according to the invention.The program may either be a part of an operating system, or be aseparate application. The carrier may be any entity or device capable ofcarrying the program. For example, the carrier may comprise a storagemedium, such as a Flash memory, a ROM (Read Only Memory), for example aDVD (Digital Video/Versatile Disk), a CD (Compact Disc), an EPROM(Erasable Programmable Read-Only Memory), an EEPROM (ElectricallyErasable Programmable Read-Only Memory), or a magnetic recording medium,for example a floppy disc or a hard disc. Further, the carrier may be atransmissible carrier such as an electrical or optical signal which maybe conveyed via electrical or optical cable or by radio or by othermeans. When the program is embodied in a signal which may be conveyeddirectly by a cable or other device or means, the carrier may beconstituted by such cable or device or means. Alternatively, the carriermay be an integrated circuit in which the program is embedded, theintegrated circuit being adapted for performing, or for use in theperformance of, the relevant procedures.

The term “comprises/comprising” when used in this specification is takento specify the presence of stated features, integers, steps orcomponents. However, the term does not preclude the presence or additionof one or more additional features, integers, steps or components orgroups thereof.

The reference to prior art in this specification is not, and should notbe taken as, an acknowledgment or any suggestion that the referencedprior art forms part of the common general knowledge in Australia, or inany other country.

1.-54. (canceled)
 55. A dialysis device receiving, via a prescriberinterface, data representing a set of therapeutic objectives and atreatment plan, which comprises a treatment schedule for a number ofconsecutive treatment sessions and a set of settings of a treatmentsession, the dialysis device comprising: a patient interface, and acomputer system receiving input data, indicative of a modified setting,via the patient interface, wherein the computer system: modifies atleast one of the settings of the set of settings based on the input datareceived via the patient interface, and re-evaluates the treatment planas a function of the at least one modified setting to generate asuggestion including at least one treatment option comprising asuggested set of settings of a treatment session to achieve said set oftherapeutic objectives.
 56. The dialysis device according to claim 55,wherein the computer system further causes the dialysis device tomeasure clinical or therapeutic parameters during a treatment sessionusing the dialysis system, wherein the suggestion of the at least onetreatment option generated during the re-evaluation step is based on afunction of the measured parameters.
 57. The dialysis device accordingto claim 56, wherein the treatment session includes at least onepreceding treatment session.
 58. The dialysis device according to claim56 or 57, wherein the suggestion of the at least one treatment optiongenerated during the re-evaluation step is generated based on the atleast one modified setting and the at least one measured parameter. 59.The dialysis device according to claim 56, wherein the suggestion of theat least one treatment option generated during the re-evaluation step isgenerated based on a function of the measured parameters during anon-going treatment session and of the measured parameters of at leastone preceding treatment session.
 60. The dialysis device according toclaim 55, wherein the suggestion of the at least one treatment optiongenerated during the re-evaluation step is presented on the patientinterface, and the computer system receives a selection inputted via thepatient interface of one of the treatment options, whereby the computersystem in response to the selection adjusts the settings as aconsequence of the selection to carry out the treatment session inaccordance with the selected treatment option.
 61. The dialysis deviceaccording to claim 55, wherein the computer system receives data via theprescriber interface of limits of variation of the at least one settingand the computer system limits the modification of each setting to bewithin the limits.
 62. The dialysis device according to claim 56,wherein the received data via the prescriber interface includes limitsof variation of the measured clinical or therapeutic parameters.
 63. Thedialysis device according to claim 62, comprising an alert configured toissue an alert upon a deviation above or below a predefined limit ofvariation.
 64. The dialysis device according to claim 55, wherein thetherapeutical objective is set to be reached over a period of a numberof treatment sessions, and wherein the re-evaluation step is configuredto take into account a treatment history and several future treatmentsessions when suggesting said at least one treatment option, to securethat the treatment objective is reached while allowing flexibility inthe individual treatment sessions.
 65. The dialysis device according toclaim 55, wherein said at least one of said settings is modified via thepatient interface during an on-going treatment session, and wherein there-evaluation step, as a consequence of the modification, generates asuggestion of at least one treatment option at one or more consecutivetreatment sessions.
 66. The dialysis device according to claim 55, whichcomprises a hemodialysis machine.
 67. A computer program productcomprising computer code which, when executed on a data-processingsystem, is adapted to carry out a method of operating a dialysis device,said dialysis device comprising a computer system and a patientinterface, the method comprising: receiving a set of therapeuticobjectives and a treatment plan, which comprises a treatment schedulefor a number of consecutive treatment sessions and a set of settings ofa treatment session, wherein the dialysis device is adapted to executethe treatment plan; receiving via a patient interface a modification toat least one of the settings of the set of settings of the treatmentsession; re-evaluating the treatment plan based on the receivedmodification of at least one of said settings, wherein the re-evaluationincludes generation of a suggestion of at least one treatment optiondetermined based on the modification of at least one setting, the set oftherapeutic objectives and the treatment plan, wherein the at least onetreatment option comprising a suggested set of settings of a treatmentsession to achieve said set of therapeutic objectives.
 68. The computerprogram product according to claim 67, wherein the method furthercomprises measuring clinical or therapeutic parameters during atreatment session and the re-evaluation step determines the at least onetreatment option as a function of the measured parameters.
 69. Thecomputer program product according to claim 68, wherein the clinical ortherapeutic parameters are measured during at least one precedingtreatment session.
 70. The computer program product according to claim68 or 69, wherein the at least one treatment option suggested in there-evaluation step is a function of the at least one modified settingand the measured parameters.
 71. The computer program product accordingto claim 68, wherein the re-evaluation step determines the at least onetreatment option as a function of the measured parameters of an on-goingtreatment session and of at least one preceding treatment session. 72.The computer program product according to claim 67, wherein there-evaluation step suggests treatment options, and the method furthercomprises receiving an input from the patient interface indicating aselection of one of the suggested treatment options and adjusting thesettings in response to the selection to carry out the treatment sessionin accordance with the selected treatment option.
 73. The computerprogram product according to claim 67, further comprising receiving dataindicating limits of variation of each of the at least one setting thatare allowed to be modified via the patient interface, thereby allowingmodification of each setting within these limits.
 74. The computerprogram product according to claim 68, further comprising receiving dataindicating limits of variation of the measured clinical or therapeuticparameters.
 75. A dialysis device receiving data representing a set oftherapeutic objectives and a prescribed treatment plan, wherein theprescribed treatment plan includes a treatment schedule for consecutivetreatment sessions and a set of settings to the dialysis device for thetreatment sessions, the dialysis device comprising: a patient interface,and a computer system receiving input data from the patient interfaceand storing the input data and the received set of therapeuticobjectives and the received prescribed treatment plan in a memory,wherein the computer system executes a computer code stored in thememory to: modify at least one of the settings of the set of settingsbased on the input data received from the patient interface, and inresponse to the modification of said at least one of the settings,re-evaluate the prescribed treatment plan and generate at least onesuggested treatment option for achieving the set of therapeuticobjectives, wherein each of the at least one suggested treatment optionincludes a set of settings to the dialysis device for one or more of theconsecutive treatment sessions.
 76. The dialysis device of claim 75wherein the re-evaluation of the treatment plan includes adjusting atleast one of the other of the settings of the set of settings in thetreatment plan.
 77. A computer program product comprising computer codewhich, when executed on a data-processing system of a dialysis device,is adapted to carry out a method of operating the dialysis device, themethod comprising: receiving by the dialysis device a set of therapeuticobjectives and a treatment plan, which comprises a treatment schedulefor consecutive treatment sessions and a set of settings of the dialysisdevice for the treatment sessions; receiving from a patient interfacefor the dialysis device a modification to at least one of the settingsof the set of settings of the treatment session; re-evaluating thetreatment plan based on the received modification of the at least one ofsaid settings, wherein the re-evaluation includes generating asuggestion of at least one treatment option, wherein the treatmentoption is determined based on the modification of the at least onesetting, the set of therapeutic objectives and the treatment plan, andwherein the at least one treatment option comprises a suggested set ofsettings of a treatment session to achieve said set of therapeuticobjectives.
 78. The computer program of claim 76 wherein there-evaluation of the treatment plan includes adjusting at least one ofthe other of the settings of the set of settings in the treatment plan.